U.S. MARKETS FOR SPINAL MOTION PRESERVING DEVICES

An estimated 50 million people in the United States (U.S.) suffer from back pain. In 2004, more than 1 million spine surgeries were performed in the U.S.--far more than the number of hip and knee replacements combined. Factors driving the growth of the spine surgery products market include growing numbers of people with degenerative disc disease, which typically is caused by gradual disc damage and often results in disc herniation and chronic, debilitating lower back pain. It is most common among otherwise healthy people in their 30s or 40s and affects approximately half of the U.S. population age 40 and older.

Degenerative disc disease has promoted an industry built on spinal fusion products and technologies; however, the spinal implants and products market has taken a complete about-turn by focusing on new technologies that maintain rather than prevent motion at the disc space. Although spinal fusion has generally worked well in alleviating back pain in the majority of patients, results are limited. Published data indicate that while 75% of lumbar fusion patients receive clinical benefit, only 50% experience significant relief of pain or complete recovery of function. Ten-year reoperation rates are reported at approximately 10%. This has led surgeons to seek new spinal technologies, such as total disc replacement, and other emerging products and systems, such as nucleus replacement, dynamic stabilization devices, and minimally invasive spinal surgery techniques--all of which have the potential to reduce pain and improve motion and long-term outcomes.

This report focuses on three core emerging spinal motion preserving device areas including: artificial discs (cervical and lumbar), nucleus replacement, and dynamic stabilization. Another nonfusion segment, minimally invasive (MI) discectomy, is also discussed. These products defined a U.S. spinal products market worth an estimated $186 million in 2004 (including MI discectomy and dynamic stabilization cleared as an "adjunct to fusion". This dynamic market is growing at an extremely fast pace, at a compound annual rate of 50%, and is projected to reach more than $1.5 billion in the year 2009 due to rapid sales of next-generation artificial discs and the U.S. Food and Drug Administration's expected approval of dynamic stabilization devices for nonfusion indications.